Are you looking for a role with impact?
We are looking for a Manager, of CMC Process Analytics to be responsible for leading process and analytics optimization for Magenta Therapeutics clinical development programs. This key position will establish and manage work plans to analyze process data from Phase II/III studies as well as manage external process and assay development in compliance with FDA regulations and those of other regulatory agencies. This role will provide the opportunity to advance state of the art Cell Therapies through late stage clinical development and into commercialization.
The successful candidate will make substantial contributions to authoring CMC sections of INDs and other filings, while managing a constructive and cooperative relationship with contract manufacturing organizations, (CMOs), clinical site(s), contract research organizations (CROs) and in-house R&D/clinical translation teams. The role has broad responsibilities across CMC functions including process development, assay development, assay validation, vendor oversight and QC. Our successful Manager, CMC Process Analytics must have the desire and history of demonstrated technical proficiency, external team management, scientific creativity, initiative, independent thinking and collaboration with others.
You are perfect for this role if you are engaged by and want to be responsible for:
- Analyzing production process data to identify trends and correlations with human clinical outcomes.
- Overseeing the on-going development of production process, product specifications and qualifications, to provide for sound production practices and robust methods/techniques which establish product characterization, identity, purity, potency, sterility, etc.
- Developing, qualifying and validating assays for clinical product with an emphasis on flow cytometry methods for both in process and product release testing.
- Collaborating with Quality and Regulatory functions as well as functional leads to maintain alignment of goals and to navigate project obstacles.
- Authoring and assembling CMC sections of regulatory filing(s) as needed.
- Periodically traveling to CMOs, CROs and clinical site(s).
You will be set up for success here if you brought the following with you:
- PhD. in bioengineering, biochemistry or related discipline with 2-5 years (or BS/MS degree with 5-10 years) of relevant experience. Experience in biologics development including cell therapy development preferred.
- Fundamental knowledge in cell biology, immunology, cell culture and cell cryopreservation principles
- Working knowledge of flow cytometry, ELISAs, cytokine assays, compendial methods for cell and gene therapy, including sterility testing required; chromatographic/mass spec methods a plus
- Strong analytical skills to perform statistical analysis as well as proficiency in Excel
- Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development, GLP/GMP experience, assay validation, Quality Systems and regulatory requirements
- Demonstrated skills in designing, executing and interpreting experiments
- Experience authoring CMC sections of regulatory documents
- Ability to perform up to 20% travel
To be successful as a leader and contributor within Magenta, you must be:
- Driven. You will be focused on the achievement of Magenta’s mission and major corporate goals.
- Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way.
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business.
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when that process may need to change.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders.
- Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company.
- A role model for the company’s cultural pillars; Courage Commitment and Excellence!